A Phase 4 interventional study of Povidone-iodine irrigation in Catheter; Infection (Indwelling Catheter), Catheter Infection and Catheter-Related Infections, sponsored by William Beaumont Hospitals. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by William Beaumont Hospitals · Phase 4, Interventional, and Prevention
Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.
Indwelling urinary catheters are routinely used in the care of hospitalized patients for a variety of reasons, including monitoring of urine output in critically ill patients, relief of urinary obstruction, and prevention of contamination of decubitus ulcers. Bacteriuria increases by 3-10% each day a catheter is left in place, meaning that by 30 days, generally 100% of patients with indwelling catheters will have bacteria in their urine. The majority of these people do not have urinary tract infections (UTIs), they are merely colonized and do not require treatment.
To define a standard (and ultimately to compare hospitals against each other), a surveillance definition for CAUTI has been developed by the National Healthcare Safety Network (NHSN). While useful for surveillance, the definition does not correlate with clinical UTIs, leading to over diagnosis and over-reporting of UTIs (in other words, those with merely bladder colonization being diagnosed as having a UTI). Despite continuing progress in standard methods of reducing infection rates (including decreasing the number of catheters inserted, ensuring proper catheter maintenance, and removing catheters when no long necessary) there continue to be unacceptably high rates of CAUTIs.
A single dose of povidone-iodine prior to catheter removal seems a novel and promising practice for several reasons. First, we suspect it will be helpful in reducing rates of NHSN defined CAUTI, as these are still diagnosed for 2 days after the catheter is removed. Second, using multiple doses of povidone-iodine would be inadvisable, since we suspect bacteria over time would become resistant even to this antiseptic. Third, we suspect use of an antiseptic is preferable to an antibacterial for preventing further antimicrobial resistance development. Finally, use of this method, as opposed to the suggested use of systemic antibiotics at time of removal, is potentially preferable from the downstream standpoint of less antimicrobial resistance and reduced risk of Clostridium difficile infection.
Exclusion Criteria:
Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal
Drug: Povidone-iodine irrigation
Catheter removal with no bladder irrigation
Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
Also known as: Betadine
Diagnosis of Urinary Tract Infection (UTI)
Per NHSN defined catheter associated UTI (CAUTI) criteria
Time frame: 48-72 hours after catheter removal
Diagnosis of UTI at 7 Days
Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
Time frame: 7 days after catheter removal
Diagnosis of UTI at 28 Days
Per NHSN defined CAUTI criteria
Time frame: 28 days after catheter removal
Patients were recruited from the inpatient units of the hospital.
| Milestone | Povidone-Iodine Irrigation | Standard of Care |
|---|---|---|
| Started | 0 | 3 |
| Completed | 0 | 1 |
| Not completed | 0 | 2 |
Per NHSN defined catheter associated UTI (CAUTI) criteria
No measurements were reported for this outcome.
Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
No measurements were reported for this outcome.
Per NHSN defined CAUTI criteria
No measurements were reported for this outcome.
Collected over 28 days; from study enrollment through the study completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Povidone-Iodine Irrigation | — | — | — |
| Standard of Care | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
No patients were randomized to the Povidone-Iodine arm
| Age, Categorical(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 3 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 0 | 3 | 3 |
| Race and Ethnicity Not Collected(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| United States | 0 | 3 | 3 |
| Presence of urinary tract infection(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
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William Beaumont Hospitals